MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number TFGT-23A

Device Problems Perivalvular Leak (1457); Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Dyspnea (1816); Pulmonary Edema (2020); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Social medial complaint.It was reported that a 23mm trifecta valve was implanted in a patient on an unknown date and year.On an unknown date we have a customer alleging a "serious issue" with their father-in-law's.

Manufacturer Narrative

B3 - date of event is estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 23mm sjm trifecta valve was successfully implanted.At the time of discharge, the patient was reportedly hemodynamically stable and symptomatically better.On (b)(6) 2023, the patient was presented with shortness of breath and chest pain.The leaflet attached to the post stent suture was noted to come out.Acute pulmonary oedema was confirmed under transthoracic echocardiogram (tte).Mild periprosthetic regurgitation was noted.There is at least moderate to severe valvular regurgitation.Medication was administered.On (b)(6) 2023, the trifecta valve was explanted.A replacement non-abbott device was implanted.The patient is reported to be stable and was discharged.

Manufacturer Narrative

Related report: (b)(4).Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6 health effect - clinical codes 4580 was removed.H6 medical device problem code 2993 was removed.

Manufacturer Narrative

An event of regurgitation, shortness of breath, and chest pain was reported in australia.It was also reported that the device was explanted in india about two weeks after this event.The device was received for investigation which found that leaflets 2 and 3 were torn.There was a think layer of fibrin on leaflets 2 and 3.A fold was present on the free edge of leaflet 3.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case histological evaluation did not reveal any changes to the tissue at the tear site, and the cause of the tears could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2022, a 23mm sjm trifecta valve was successfully implanted in india.At the time of discharge, the patient was reportedly hemodynamically stable and symptomatically better.On (b)(6) 2023, the patient was presented to a hospital in australia with shortness of breath and chest pain.The leaflet attached to the post stent suture was noted to come out.Acute pulmonary edema was confirmed under transthoracic echocardiogram (tte).Mild periprosthetic regurgitation was noted.There is at least moderate to severe valvular regurgitation.Medication was administered.On (b)(6) 2023, the patient traveled back to india and had the trifecta valve explanted.A replacement non-abbott device was implanted.The patient is reported to be stable and was discharged.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18414018
• MDR Text Key: 331552772
• Report Number: 2135147-2023-05779
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: 05415067018229
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 7729493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization